Betnesol Tablets

/ Devries & Co.

Glucocorticoidsshould only be administered at lowest therapeutic required doses and as long as it is absolutely necessary to achieve and maintain the desired therapeutic effect.
The dosage must be adjusted to the specific situation of the patient, considering severity of disease of the occurred effect and glucocorticoid tolerance.
Adults and adolescents as of 12 years: The daily dose is administered usually in the morning and at once as this will less affect the rhythm of adrenal cortex-secretion.
Short-term treatment: Acute asthma attacks, Pillinosis or other allergic diseases of the respiratory tract, generalised eczema, urticaria, dermatitis medicamentosa, and various inflammatory skin diseases.
6 tablets in the morning for 2 days, followed by 1 tablet in the morning for 2 days, followed by ½ tablet in the morning for 2 days.
Arthritis rheumatica: 1 -4 tablets (0,5 mg to 2 mg) daily in the morning for 1 – 2 weeks, then a gradual withdrawal of the treatment, starting with one tablet less a day, later half a tablet less, by keeping each dosage for one week. Thus it is possible to evaluate the minimum effective dose.
Other diseases: Betnesol effervescent tablets is indicated particularly for patients with nephrosis since it shows nearly no sodium chloride and water retention effect. In this disease the usual dose is 1–8 tablets (0,5 mg to 4 mg) daily in the morning for 1 to 3 weeks, maybe also longer.
Then the medication is withdrawn step by step. To reach the therapeutic effect in pemphigus, erythematodes or collagenoses of the skin often higher doses are required.
Dosage in children as of 6 years: The effects of glucocorticoids on the pathophysiology and history of the disease are considered similar in adults and children.
In children in general lower doses than indicated above are sufficient, but the dosage should be adjusted more to the severity of the disease than to age, body weight, or body size. After sufficient response Betnesol should be withdrawn step by step as quickly as possible. Long-term treatment is not recommended. Exact dosages have been not been established in clinical trials. From clinical
experience following guidelines for short-time treatment were shown:
Recommended initial dose: 7 to 12 years: up to 8 tablets/day (=4 mg).
Elderly: Caution is advised on higher frequency of adverse events in older patients during administration of betamethasone particularly in long-term therapy including osteoporosis, worsening of diabetes, hypertension, susceptibility to infections and thinning of the skin.
Patients with impaired liver function and thyroid disease: Betamethasone is basically metabolized in the liver. In patients with hepatic insufficiency or hypothyroidism relatively low doses may be sufficient or dose reduction may be required.
See prescribing information for full details.

Diseases responsive to oral glucocorticosteroid therapy.

Hypersensitivity to the active substance or to any of the excipients.
Contraindicationsfor administration beyond emergency therapy:
Systemic mycosis
Ulcus ventriculi
Ulcus duodeni
Severe osteoporosis
Myopathies (excluding Myasthenia gravis)
Virus diseases (e.g. varicella, herpes simplex, herpes zoster – viremic phase))
Poliomyelitis with the exception of bulbar encephalitic form)
Lymphomas following BCG – immunization
Approximately 8 weeks before and 2 weeks after immunization or 1 year after a BCG
vaccination
Narrow-angle glaucoma and open-angle glaucoma
Manifest or latent tuberculosis
Amoebic infections
Anamnestic psychoses
Herpes keratitis
Children below 6 years

In view of the potential of serious side effects and withdrawal problems, therapy should be carefully considered. High dose, short term therapy (1-3 days) can be withdrawn abruptly or slowly over 1 week. In therapy for more than one week, withdrawal should be conducted in a slow decremental fashion over several weeks. Even after cautious withdrawal, patients may need supplements during periods of stress. The lowest dose that can control the disease should be used. Steroid therapy in children necessitates careful consideration due to growth retard action. Pregnancy and lactation: Corticosteroids cross the placenta and have been associated with placental insufficiency, low birth weight and neonatal adrenal suppression. Adrenal function of the nursing infant may be affected.
See prescribing information for full details.

See prescribing information for full details.

Phenytoin, barbiturates, carbamazepine, aminoglutethimide, rifampicin. Thiazide and loop diuretics, cardiac glycosides, acetazolamide. Oral hypoglycemics, insulin. Antihypertensives, anabolic steroids, ophthalmic idoxuridine, NSAID.
See prescribing information for full details.

Pregnancy: There are no controlled studies on the administration of betamethasone during pregnancy and lactation available.
In animal studies the use of glucocorticoids lead to fetal malformations. An
increased risk of cleft palate in human fetus by administering of glucocorticoids during the first trimester is discussed. If gucocorticoids are administered at the end of pregnancy, there is a risk for the fetus for atrophy of the adrenal cortex, which may require a compenastive substitution treatment of the newborn. Furthermore they have to be tested for rare occurrence of congenital cataracts.
For this reason, Betnesol should only be adminiserted during pregnancy if the expected benefit outweighs the potential risk for the fetus.
Basically no cortisone-containing medicinal products should be administered in the first 3 months of pregnancy.
Breastfeeding: Since glucocorticoids penetrate breast milk in small quantities, it has to be weaned during a glucocorticoid therapy.

In acute overdose with glucocorticoidsincluding betamethasone a life-threatening situation is not to be expected. Also at extremely high doses, an excessive doses of glucocorticoid over some days will not lead to any risk for the patient, if special contraindicationssuch as diabetes, glaucoma, gastrointestinal
ulcera, as well as concomitant treatment with potassium sparing diuretics, Digitalis, anticoagulants(coumarin type) can be excluded.
Possibly occurring undesirable events due to glucocorticoids must be treated symptomatic accordingly. For ulcer prophylaxis, H2 receptor antagonist or antacid should be administered. In diabetics blood glucose levels must be monitored and antidiabetic drugs dose hast to be increased if necessary. At increased risk of infection an antibiotic therapy may be necessary.
Treatment: Symptomatic; Adequate hydration. Check of electrolytes in serum and urine, in particular the balance of sodium and potassium. Electrolyte imbalance is to compensate.
An antidote for betamethasone is not known.